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FDA Compounding Enforcement Under Fire from Lawmakers, Industry.

Wed, 03/05/2014 - 17:33

FDA facing accusations from lawmakers and the compounding pharmacy lobby that it is overreaching.

Just three months after gaining new authority over compounders, the FDA is facing accusations from lawmakers and the compounding pharmacy lobby that it is overreaching its new role and retroactively applying a new federal law.

The International Academy of Compounding Pharmacists (IACP) pointed to warning letters delivered to three pharmacies last month — and published by the agency Tuesday — that illustrate its concerns. The warning letters to Wedgewood Village Pharmacy of Swedesboro, NJ, Pallimed Solutions of Woburn, MA, and Indianapolis, Indiana-based Nora Apothecary Pharmacy, identify good manufacturing practices violations.

The IACP’s chief concern is each pharmacy was inspected roughly a year or more ago. Wedgewood’s inspection, for example, started in November 2012.

The Drug Quality and Security Act, which strengthened the FDA’s authority over compounders, didn’t become law until November 2013.

The agency cited its new authorities in the three warning letters, noting that each company was producing compounded drugs without a prescription when they were inspected.

The IACP believes the warning letters open “some fundamental questions about due process, fairness and the protection of individual rights when a government agency can use a new law to question past activity,” spokesman David Ball told DID Tuesday.

“FDA should not be invoking laws that were not in effect at the time of inspections,” said Derek Shaffer, an attorney representing Wedgewood. The pharmacy is also crafting a response to the warning letter.

Tackling Office Use

Rep. Morgan Griffith (R-VA) is also concerned with the agency’s recent spate of pharmacy enforcement. Griffith, however, is more concerned that the agency is unfairly targeting compounded drugs for office use — drugs that are compounded without a prescription, and dispensed to hospitals, doctors' offices and other healthcare settings.

The FDA previously did not target office use of compounded drugs for oversight, and gave assurances during negotiations on the Drug Quality and Security Act that it would maintain that stance, Griffith told DID.

Last year, Griffith and Reps. Gene Green (D-Texas) and Diana DeGette (D-Colo.) introduced legislation proposing restrictions on office use (DID, Sept. 12, 2013). Under that bill, after the compounded drug was administered to a patient, a physician must submit a prescription for the drug to the compounder within seven days.

Griffith said he would speak with Green and DeGette to decide how to revive the issue.